INTRODUCTION TO PHARMACOLOGY

Similar documents
How do drugs work? Part 1. PK: Principles & Processes. PK vs. PD. Pharmacokinetics : Basic Principles Overview. What does the body do to a drug?

European Medicines Agency Evaluation of Medicines for Human Use COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT

INTRODUCTION TO CLINICAL PHARMACY

FORENSIC SEROLOGY. Chapter PRENTICE HALL 2008 Pearson Education, Inc. Upper Saddle River, NJ 07458

Design and Dosage Form. Dr. Deny Susanti

Pharmacokinetic & Pharmacodynamic Data Analysis

BASIC PHARMACOKINETICS AND PHARMACODYNAMICS

Expert Intelligence for Better Decisions Macrocycles:

Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products

PHARMACOKINETICS. Dr. M.Mothilal Assistant professor

参考資料. Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products. Draft

BIOPHARMACEUTICS AND PHARMACOKINETICS

BIOPHARMACEUTICS AND PHARMACOKINETICS. University of Alcalá. Academic year 2016/17 3 rd Year 1 st Season

PK and PK/PD Guided Starting Dose Selection for First-In-Human Trials. Sylvia Zhao ( 赵子微 ) Translational Clinical Oncology Novartis

Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products

What s the difference? Challenges in pre-clinical development of biologics

Assays for Immunogenicity: Are We There Yet?

Biological Sample Collection

Unique PK-PD properties of biotechnology-based therapeutics [mabs] and First In Human dose considerations. [mabs -monoclonal antibodies ] Peter Lloyd

Biomath M263 Clinical Pharmacology

Predicting Tissue Distribution & Clearance of Antibody Formats to Improve Selectivity of Targeted Therapies

Value Scale (1-5) 1 I. Final Product Profile Characteristics of the product required for patient care

Quantitative And Spatial Optimization Of Therapeutic Fusion Proteins

Step-by-Step Description of ELISA

PRECLINICAL DRUG DISCOVERY AND DEVELOPMENT BIOBOOT CAMP 2016

Preclinical pharmacokinetics and pharmacodynamics of AG-519, an allosteric pyruvate kinase activator

Study (s) Degree Center Acad. Period Grado de Farmacia FACULTY OF PHARMACY 3 Annual PDG Farmacia-Nutrición Humana y Dietética

In vitro mechanistic studies on Metabolism-Dependent Inactivation of Cytochrome P450 Enzymes

Human alkaline phosphatase,alp ELISA kit

The course is taught by a team of UNC faculty and industry scientists. The course has been designed to provide the students an understanding of

Policy 19 Fluid Administration and Collection in Rodents Version 1.0 Approval Date: 12/12/12

Doctor of Pharmacy Course Descriptions

Official Letter from the DOH

Human IgG ELISA Quantitation Set

Controlling drug delivery

Main Content Domain % of Operational Items # of Operational Items

Transferrin ELISA. For the quantitative determination of transferrin in human biological samples

Graduate Courses: Advanced Pharmaceutics Prerequisites: Course No: Instructor: Credits: Description:

RayBio Phospho- Stat 3 (Tyr705) ELISA Kit

Antigen-antibody reactions with labeled reagents

TIDES 2014 GalNAc-siRNA with Enhanced Stabilization Chemistry: ESC-GalNAc-siRNA. May 14, 2014 Muthiah Manoharan

Preclinical Drug Development

Use of Antisense Oligonucleotides for the Treatment of Inheritable Rare Disorders. C. Frank Bennett Isis Pharmaceuticals

MyBioSource.com. Human VEGF ELISA Kit

DDI Assessment for Therapeutic Proteins and ADCs

ELISA IMMUNOASSAY FOR HUMAN

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

Public Assessment Report Scientific discussion. Desogestrel Orifarm (desogestrel) SE/H/888/01/DC

The Role of a Clinical Statistician in Drug Development By: Jackie Reisner

Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Protocol for Albuwell M kit: Murine Microalbuminuria ELISA By Exocell Inc

Abstract. Technical Aspects. Applying GastroPlus for Extensions of Biowaivers for BCS Class II Compounds 2

ELISA IMMUNOASSAY FOR DISEASE DETECTION

For the quantitative detection of human IL6 in serum, plasma, cell culture supernatants and urine.

Drug Development: Why Does it Cost so Much? Lewis J. Smith, MD Professor of Medicine Director, Center for Clinical Research Associate VP for Research

Anti- Tissue Transglutaminase TTG IgG ELISA Kit

Human Myostatin, ELISA Kit (MSTN)

Formulation Development of New Chemical Entities (NCEs) Dr. Mariella Artusi Pharmaceutical Development Dept. Monza

Global Headquarters 86 Cummings Park Woburn, MA Tel:

Mouse ICAM-1 / CD54 ELISA Pair Set

The TetraQ Difference. Quality Preclinical Drug Development Solutions. Provide advice and tailored solutions, not just a menu of choices

Human Collagen Type III (COL3) ELISA

Antibody-drug Conjugates: Characterization and Control Strategies of Lysine-linked Products

Injectable modified release products

drug discovery: Where are we now? How did we RSC February 2013

Rat IGF-1 ELISA Kit (rigf-1-elisa)

Zool 3200: Cell Biology Exam 3 3/6/15

From Molecules To Medicine

H-ferritin (Human) ELISA Kit

Human TGF-beta1 ELISA

Cosmetics Europe LRSS Programme

Eurofins ADME BIOANALYSES Your partner in drug development

Biomedical accelerator mass spectrometry: recent applications in metabolism and pharmacokinetics

Public Assessment Report Scientific discussion

Store samples to be assayed within 24 hours at 2-8 C. For long-term storage, aliquot and freeze samples at -20 C. Avoid repeated freeze-thaw cycles.

Strategies for Assessment of Immunotoxicology in Preclinical Drug Development

Rat TNF-α ELISA REF. Ver5.0 RUO. ELISA Set for Accurate Quantitation from Cell Culture Supernatant, Serum, Plasma or Other Bodily Fluids

Mouse Luteinizing Hormone (LH) ELISA

Mouse Peptide YY (PYY) ELISA

Human IL-10 ELISA MAX Set Deluxe

HiPer Sandwich ELISA Teaching Kit

colorimetric sandwich ELISA kit datasheet

Xenobiotic Biotransformation. Michael A. Trush, PhD Johns Hopkins University

Content Areas of the Pharmacy Curriculum Outcomes Assessment (PCOA )

**MATERIAL SAFETY DATA SHEET**

RayBio Phospho- Akt (Ser473) ELISA Kit

Human Corticosterone ELISA Kit

Design and Validation of a Non Cell-based Receptor Binding Assay for the Detection of Neutralizing Antibodies to a Biological Therapeutic

Your Analyte ELISA Kit Instruction

Cytomics in Action: Cytokine Network Cytometry

Enzyme Linked Immunosorbent Assay for Horseradish Peroxidase Labeled Antibodies. (Cat. # )

2. Sample dilution: Tissue lysate and cell lysate sample should be diluted at least 5-fold with 1x Sample Diluent Buffer.

Development of Multiplex Sensitive Anti-Drug Antibody Assays for CRISPR/Cas9 Gene Therapies

Chapter 10. Antimicrobials. PowerPoint Lecture Slides for MICROBIOLOGY ROBERT W. BAUMAN

THE INNOVATION COMPANY HEALTH. Institute for Biomedicine and Health Sciences

MOUSE ENDOTHELIAL- CELL SPECIFIC MOLECULE- 1 (ESM-1) ELISA KIT

Fibrinogen ELISA. For the quantitative determination of fibrinogen in biological fluids, serum, and plasma.

Industry Academic Collaboration: A Key to Successful Involvement of Patients Early in Clinical Development

SAMPLE LITERATURE Please refer to included weblink for correct version.

Porcine IgM (Immunoglobulin M) ELISA Kit

Transcription:

INTRODUCTION TO PHARMACOLOGY Pharmacology is the study of how chemicals interact with the body Endogenous hormones, growth factors, etc Exogenous drugs Two areas of study Pharmacodynamics Interaction of chemicals with receptors or enzymes Pharmacokinetics Absorption, distribution, metabolism, excretion 1

Pharmacokinetics What the body does to a drug LADME Liberation Absorption Distribution Metabolism Excretion 2

Pharmacokinetics Routes of drug administration Oral Sublingual Intravenous (IV) Intraperitoneal (IP) Intramuscular (IM) Subcutaneous (SC) Rectal Epidural Intracerebroventricular 3

Liberation Pharmacokinetics How is a drug released from its delivery vehicle? Pills must dissolve or be broken down Forms of oral medications Tablet Caplet Liquid Liqui-Gel 4

Absorption Pharmacokinetics How is a drug absorbed into the tissue or bloodstream? Depends on route of administration Oral absorbed via gastrointestinal tract; goes to liver Sublingual absorbed via blood vessels under the tongue; bypasses the liver IV n/a IP absorbed via peritoneal mucosae IM absorbed via muscle lymphatics & capillaries Bioavailability: how much ingested drug is actually absorbed? 5

For an orally-administered medication, absorption can only occur once which of these other processes has occurred? A) Distribution B) Metabolism C) Liberation D) Excretion 6

Why does the previous question include the qualifer, For an orally-administered medication? 7

Distribution Pharmacokinetics How is a drug distributed to the various fluid compartments or tissues of the body? Plasma vs. interstitial vs. intracellular fluid Adipose tissue vs. lean tissues Distribution is unequal & distinct for each drug Volume of distribution theoretical volume a drug would occupy if it were present in all compartments at the same concentration as in the plasma 8

Volume of distribution is based MOSTLY on A) how much blood a patient has. B) how much drug was in a particular pill. C) how soluble a particular drug is in lipids vs. water. 9

True or false: The volume of distribution of a drug may be larger than the total volume of the patient. A) True B) False 10

Metabolism Pharmacokinetics Is a drug chemically modified by the body? If so Are the metabolites more or less active? Are the metabolites safer or more toxic? Can the metabolites be more easily excreted? Which tissues metabolize the drug? What enzyme systems or other reactions are used to metabolize the drug? 11

Metabolism Phase I reactions Pharmacokinetics Liver Cytochrome P450 (cyp450) enzymes E.g., Oxidation, reduction, hydrolysis, (de)cyclization Often produce active metabolites First-pass effect Phase II reactions Liver and kidney Addition of polar functional groups Usually produce non-functional metabolites for excretion E.g., Glucuronidation, glutathione conjugation 12

Pharmacokinetics Metabolic clearance of drugs / hormones Metabolized into non-active form Bound to cells & degraded / recycled Excreted These processes are not mutually exclusive Drugs can be metabolized to inactive metabolites, then excreted 13

Pharmacokinetics Metabolic clearance of drugs / hormones Rate of removal depends on solubility Peptide hormones Degraded in blood or tissues Cleared rapidly (seconds to minutes) Steroid hormones Bounds to plasma proteins Cleared slowly (minutes to days) 14

Drug / Hormone Clearance Metabolic clearance rate (MCR) Rate of disappearance from plasma Infuse at increasing rate until plasma concentration reaches steady-state Infusion rate = rate of disappearance Concentration of hormone in plasma MCR (ml/min) = rate of hormone disappearance (ng/min) Concentration of hormone (ng/ml) 15

Pharmacokinetics Excretion / Elimination Urine Feces Breath Skin 16

Metabolic clearance rate refers to A) How fast kidneys produce urine. B) How much drug is filtered by the kidneys. C) A theoretical volume of plasma that can be 100% cleared of drug in a particular amount of time. 17

Pharmacodynamics What a drug does to the body Drug (ligand)-receptor interactions L + R L R Receptor types membrane vs. intracellular Enzymes & structural proteins can act as drug receptors Signal transduction pathways Enzyme-based biochemical pathways 18

Pharmacodynamics Potential actions/roles of drugs Agonist Stimulating action vs. depressing action Full or partial agonist Antagonist Direct beneficial chemical reaction Direct harmful chemical reaction 19

Pharmacodynamics Dose-response curves Increased [drug] increased effect EC 50 (effective dose yielding 50% max effect) Curve shifts Upward higher efficacy Leftward higher potency (sensitivity) 20

Tension (mn/mm) Tension (mn/mm) Pharmacodynamics 125 100 LPO AdLib (n=15) NPO AdLib (n=11) NPO FR (n=5) LPO FR (n=8) 160 140 120 100 75 50 80 60 40 25 0 0 50 100 150 KCl (mm) 20 0 0.1 1 10 NorEpi (nm) 100 1000 10000 100000 21

A leftward shift of a dose-response curve indicates that a system A) is more senstive to a particular ligand. B) is less sensitive to a particular ligand. C) has a higher concentration of ligand. C) has a lower concentration of ligand. 22

Pharmacodynamics Beneficial actions of drugs must be weighed against unintended, harmful effects Side effects Therapeutic window The range of doses which provide benefits without producing toxicity Varies for each drug and may vary between individuals 23

True or false: Medications with side effects are not approved by the FDA. A) True B) False 24

Measurement of Hormone Concentration Radioimmunoassay Use specific antibody to detect hormone Mix radioactive tracer hormone, antibody and sample together Competitive assay: [Ab] is lower than combined tracer and endogenous [hormone] Remove all unbound mixture, leaving Ab bound to either tracer or endogenous hormone High [endogenous hormone] low tracer Low [endogenous hormone] high tracer 25

Measurement of Hormone Concentration Radioimmunoassay Measure radioactivity of remaining sample, compare to standard curve Fig. 74-9 26

Measurement of Hormone Concentration ELISA (enzyme-linked immunosorbent assay) Coat sample wells with antibody Add test sample Add antibody conjugated to enzyme Add enzyme substrate Fig. 74-10 Color development indicates presence of test substance; concentration determined by dilution factor & comparison to standard curve 27

Mouse ICAM-1 ELISA Standard Curve https://www.thermofisher.com/order/catalog/product/emicam1

What kind of molecule is used as a molecular tool to measure how much of a particular substance a sample has? A) Protein B) Receptor C) DNA D) Antibody 29

RIA standard curves have a negative slope; ELISA standard curves are positive. Why are they different? 30